A Phase 1 interventional study of carboplatin and cidofovir in Cervical Cancer and Precancerous Condition, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Status unknown at 1 site in France. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-01-28.
Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Phase 1, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs such as cidofovir may make tumor cells more sensitive to radiation therapy. Giving cidofovir together with radiation therapy and chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of cidofovir in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer who are receiving chemotherapy together with radiation therapy.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of cidofovir.
Patients receive cidofovir IV weekly for 2 weeks prior to beginning radiotherapy and then once biweekly during radiotherapy. Patients undergo external pelvic radiotherapy for 5 weeks. Beginning ≤ 2 weeks later, patients undergo utero-vaginal brachytherapy. Some patients may also undergo a second course of external radiotherapy to the parametrium and/or lymph nodes ≤ 3 days after brachytherapy. Patients also receive concurrent carboplatin IV once weekly during external radiotherapy and brachytherapy.
Biological expression of HPV oncoproteins E6 and E7 is analyzed during treatment.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 24 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 242 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of squamous cell carcinoma or adenocarcinoma of the cervix
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Maximum tolerated dose of cidofovir
This study is status unknown, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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Gustave Roussy, Cancer Campus, Grand Paris